FDA.reportPublic FDA data

WIKI Drain, 15 Fr, 3 cm, 1 Drain

Primary DI
00861838000330
Brand
WIKI Drain, 15 Fr, 3 cm, 1 Drain
Company
TOOLS FOR SURGERY, LLC
Model
WIK-15-3-1
Catalog number
WIK-15-3-1
Device description
The WIKI Drain™ is a flanged quadruple-lumen silicone channel drain. Package of 1, 15 Fr, 3 cm drain.
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861838000330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861838000330008618380003308618380003300861838000330

GMDN Terms#

Term, Definition table
TermDefinition
Surgical capillary wound drain, non-luminalA sterile device, without a lumen, designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically available as a corrugated drainage sheet or ribbon made of non-latex materials [e.g., polyvinyl chloride (PVC), silicone], and may include radiopaque markers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3Centimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
841842441
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00860013482114ZZIREN® Orogastric TubeZZ-SGT-32ZZ-SGT-322025-11-21
00860013482121ZZIREN® Orogastric TubeZZ-GBT-36ZZ-GBT-362025-11-21
00860013482138ZZIREN® Orogastric TubeZZ-SGT-36ZZ-SGT-362025-11-21
00860013482145ZZIREN® Orogastric TubeZZ-GBT-40ZZ-GBT-402025-11-21
00860013482152ZZIREN® Orogastric TubeZZ-SGT-40ZZ-SGT-402025-11-21
00860002701387Circular Stapler Anvil Sizer SetANS-10ANS-102023-07-19
00860002701394Circular Stapler Head Sizer SetHSS-10HSS-102023-07-19
00860002701325Barbell Loop Ostomy DeviceBAR-2BAR-22023-07-17
00860002701349Barbell Loop Ostomy DeviceBAR-3BAR-32023-07-17
00860002701356Barbell Loop Ostomy DeviceBAR-4BAR-42023-07-17
00860002701363SIREN SGTSGT-36SGT-362023-07-17
00861838000347WIKI Drain, 15 Fr, 3 cm, 6 DrainsWIK-15-3-6WIK-15-3-62023-07-17
00860002701318Colorectal Air Syringe-OP EXALT-30EXALT-30EX2019-12-17
00860002701332Colorectal Air Syringe-LP EXALT-50EXALT-50EX2019-12-17
00861838000354Colorectal Air Syringe-OPALT-30ALT-302019-09-26
00861838000361Colorectal Air Syringe-LPALT-50ALT-502019-09-26
00861838000378Bariatric Air SyringeALT-BAALT-BA2019-09-26
00861838000316Hemorrhage Occluder Pin with ApplicatorHOP-APHOP-AP2019-09-26
00861838000309Hemorrhage Occluder PinHOP-03HOP-032019-09-19

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Primary DI, Brand, Company table
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10801902210408ARROWTELEFLEX INCORPORATEDGBX2022-11-09
10801902194005ARROWTELEFLEX INCORPORATEDGBX2022-11-08
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